Sleep Difficulties in Pediatric Anxiety DisorderNCT00787397
Sleep, Mood, and Behavior Study
A study testing Cognitive Behavioral Therapy-Sleep in people with Sleep Difficulties in Pediatric Anxiety Disorder and Generalized Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Sleep Difficulties in Pediatric Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Therapy-Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
- Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, " Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)"
- The child/adolescent must have a "sleep problem" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains:
- difficulties going to sleep
- difficulties waking during the night
- difficulties getting up on time for school because of tiredness/sleepiness
- daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep
- erratic sleep-wake schedules
Who cannot join
- IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
- Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
- Acutely suicidal or at risk for harm to self or others.
- Any motor impairments or eye-hand coordination problems
- Sleep disorder or parasomnia.
- Taking any medication that might interfere with sleep.
- Has a medical problem that might interfere with sleep.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth
The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.
Read the detailed description
This study is one of two interlinking protocols developed to investigate neural, affective, behavioral and social predictors of improvement as a critical next step in advancing the understanding of processes involved in the treatment response of anxiety disorders in youth. This protocol will offer a six to eight session sleep intervention (Sleeping Tigers)children ages 9-13 who currently have a DSM-IV anxiety disorder and who endorse some level of impairment in their ability to sleep. Participants will have completed a 16 session intervention for anxiety (IRB submission, Child Anxiety Treatment Study CATS). We hope to assess whether improving sleep will further enhance affective, clinical, and social functioning.
- Conditions
- Sleep Difficulties in Pediatric Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia
- Being tested
- Cognitive Behavioral Therapy-Sleep
- Keywords
- Sleep difficulties in pediatric anxiety disorder, Neural correlates of pediatric anxiety disorder, Social correlates of pediatric anxiety disorder, Generalized Anxiety Disorder in pediatric populations, Separation Anxiety Disorder in pediatric populations, Social Phobia in pediatric populations
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety, Separation, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy-SleepBehavioural
Cognitive Behavioral Therapy: 6 sessions of CBT
| Study group | Role | What they receive |
|---|---|---|
| 1. Cognitive Behavioral Therapy-Sleep | Experimental | Cognitive Behavioral Therapy-Sleep Receives: Behavioral: Cognitive Behavioral Therapy-Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of sleep therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations.
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Difficulties in Pediatric Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Neal Ryan, University of Pittsburgh
- Investigators
- Neal D Ryan, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787397
- Sponsor's protocol ID
- PRO08010426
- Other IDs
- P50MH080215-01A1
- Status last verified
- Jan 2016
- First submitted
- 5 Nov 2008
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth
- ClinicalTrials.gov ID
- NCT00787397
- Acronym / sponsor ID
- PRO08010426
- Conditions
- Sleep Difficulties in Pediatric Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia
- Keywords
- Sleep difficulties in pediatric anxiety disorder, Neural correlates of pediatric anxiety disorder, Social correlates of pediatric anxiety disorder, Generalized Anxiety Disorder in pediatric populations, Separation Anxiety Disorder in pediatric populations, Social Phobia in pediatric populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.
Detailed description
This study is one of two interlinking protocols developed to investigate neural, affective, behavioral and social predictors of improvement as a critical next step in advancing the understanding of processes involved in the treatment response of anxiety disorders in youth. This protocol will offer a six to eight session sleep intervention (Sleeping Tigers)children ages 9-13 who currently have a DSM-IV anxiety disorder and who endorse some level of impairment in their ability to sleep. Participants will have completed a 16 session intervention for anxiety (IRB submission, Child Anxiety Treatment Study CATS). We hope to assess whether improving sleep will further enhance affective, clinical, and social functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Cognitive Behavioral Therapy-Sleep | Experimental | Behavioral: Cognitive Behavioral Therapy-SleepCognitive Behavioral Therapy-Sleep |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
- Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, " Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)"
- The child/adolescent must have a "sleep problem" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains:
Key exclusion criteria (7 listed)
- IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
- Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
- Acutely suicidal or at risk for harm to self or others.
- Any motor impairments or eye-hand coordination problems
- Sleep disorder or parasomnia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy-SleepCognitive Behavioral Therapy: 6 sessions of CBT | Behavioural | 1. Cognitive Behavioral Therapy-Sleep |
Primary outcome
Evidence of sleep therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations.
Time frame: 6 to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal D Ryan, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy-Sleep in people with Sleep Difficulties in Pediatric Anxiety Disorder and Generalized Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of sleep therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. (time frame: 6 to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.